China Consults on GMP for Pharmaceutical Packaging Materials
On June 2, China National Medical Products Administration (NMPA) released the draft of Good Manufacturing Practice of Pharmaceutical Packaging Materials (hereafter referred to as Packaging GMP) for public comments.
The Packaging GMP specifies basic requirements for the manufacturing management and quality control of pharmaceutical packaging materials.
Contents
1. Application Scope of Packaging GMP
2. Contents of Packaging GMP
3. Packaging GMP Requirements
4. GMP for Pharma Industry
1. Application Scope of Packaging GMP
Pharmaceutical packaging materials refer to
- Packaging materials and containers that have direct contact with pharmaceuticals;
- Functional secondary packaging materials, surface printing materials, components, and drug delivery devices & systems.
The Packaging GMP applies to the overall manufacturing process of pharmaceutical packaging materials, including
- all the critical factors that affect the packaging materials’ quality, and
- all the organized and planned activities to ensure the packaging materials accord with the intended uses.
2. Contents of Packaging GMP
| GMP for Pharmaceutical Packaging Materials (Consultation Draft) | ||
| Chapter 1 | General Principles | |
| Chapter 2 | Quality Management | Section 1: Principles |
| Section 2: Internal Review and Administrative Evaluation & Audit | ||
| Chapter 3 | Institution and Personnel | |
| Chapter 4 | Factory and Facility | |
| Chapter 5 | Equipment | |
| Chapter 6 | Material and Product | |
| Chapter 7 | Verification and Validation | |
| Chapter 8 | Document Management | Section 1: Principles |
| Section 2: Standard Procedures for Manufacturing | ||
| Section 3: Batch Manufacturing Record | ||
| Chapter 9 | Manufacturing Management | Section 1: Principles |
| Section 2: Manufacturing Process Control | ||
| Section 3: Clean Production and Pollution Control & Management | ||
| Section 4: Manufacture Labeling (for Containers, Equipment, and Facilities) | ||
| Section 5: Product Storage and Transport | ||
| Chapter 10 | Quality Control and Quality Assurance | |
| Chapter 11 | Entrusted Manufacturing & Testing | |
| Chapter 12 | Product Delivery, Transport, and Recall | |
| Chapter 13 | User Management Service | |
| Chapter 14 | Glossary | |
3. Packaging GMP Requirements
3.1 Internal Audit and Administrative Evaluation
Every year, a pharmaceutical packaging material manufacturer should conduct at least one internal review and at least one administrative evaluation & audit for its quality management system (QMS).
To entrust the audit to an external party, the manufacturer should make standard procedures for the external GMP audit, specifying the qualification requirements, principles for selection, and the procedures for approving the auditor.
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